U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Uncomplicated Gonorrhea: Developing Drugs for Treatment
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Uncomplicated Gonorrhea: Developing Drugs for Treatment August 2015

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2014-D-0640
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of uncomplicated gonorrhea.2 Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the overall development program and clinical trial designs for antibacterial drugs for the treatment of uncomplicated gonorrhea.

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2014-D-0640.

Back to Top